The FDA warned consumers not to rely on asthma products labeled as homeopathic that are sold over-the-counter (OTC). These products have not been evaluated by the FDA for safety and effectiveness.
Asthma is a serious, chronic lung condition. If asthma is not appropriately treated and managed, patients may have wheezing, shortness of breath, and coughing, and could be at risk for life-threatening asthma attacks that may require emergency care or hospitalization. Uncontrolled asthma can lead to chronic lung disease and a poor quality of life, and may slow growth. Although there is no cure for asthma, there are many prescription asthma treatments approved by the FDA as safe and effective, as well as some products that are marketed OTC in accordance with an FDA monograph.
Consumers with asthma can take an active role in managing their condition by making certain they have appropriate treatments on hand in the event they experience an asthma attack or a worsening of asthma symptoms, and by consulting with a health care provider when needed.
OTC asthma products labeled as homeopathic are widely distributed through retail stores and via the internet. Many of these products are promoted as “natural,” “safe and effective,” and include indications that range from treatment for acute asthma symptoms, to temporary relief of minor asthma symptoms. In general, consumers can identify such products by looking for the word “HOMEOPATHIC” or “HOMŒOPATHIC” on a product’s label and looking for whether the product’s active ingredient(s) are listed in terms of dilution (e.g., “LM1” "6X" or "30C").
Today the homeopathic drug market has grown to become a multimillion dollar industry in the United States, with a significant increase shown in the importation and domestic marketing of homeopathic drug products. Those products that are offered for treatment of serious disease conditions must be dispensed under the care of a licensed practitioner. Other products, offered for use in self-limiting conditions recognizable by consumers, may be marketed OTC.
While asthma is never "cured," a variety of FDA-approved medications can help manage symptoms. For quick relief of severe symptoms, doctors will prescribe "rescue" medications, such as albuterol, which open up the bronchial tubes in the lungs. "The goal is not to use it, but have it available—at home, school, camp—just in case," says Anthony Durmowicz, M.D., a medical officer in the FDA's Center for Drug Evaluation and Research. To stabilize chronic and persistent symptoms, doctors will prescribe "controller" medications. The most common, safe and effective controller medications are the inhaled corticosteroids (ICS). With regular treatment, they improve lung function and prevent symptoms and flare-ups, reducing the need for rescue medications. Children whose asthma is triggered by airborne allergens (allergy-causing substances), or who cannot or will not use ICSs, might take a type of drug called a leukotriene modifier. These come in tablet and chewable forms, though for many people they tend to be less effective than ICSs, especially for more severe asthma. For more severe cases that are not controlled with ICSs or leukotriene modifiers alone, adding long-acting beta agonists (LABAs) such as salmeterol or formoterol might be recommended. The FDA cautions against using LABAs alone without an ICS, and recommends that if one must be used, it should be for the shortest time possible.
See the FDA Drug Safety Announcement
See also Medical Law Perspectives, April 2015 Report (to be published April 1, 2015): Chronic Obstructive Pulmonary Disease
See also Medical Law Perspectives, May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication